510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OKJClass II

Light Based Treatment For Cold Sores Herpes Simplex Virus-1

21 CFR 878.4860 / General, Plastic Surgery
FDA source (opens on fda.gov)

OKJ is the FDA product code for Light Based Treatment For Cold Sores Herpes Simplex Virus-1, a class II device type, regulated under 21 CFR 878.4860. FDA's definition for this code reads: "Shortens time to healing of herpes simplex lesions on the lips, with time to healing defined as the time to patient described re-epithelialization". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OKJ
Device name
Light Based Treatment For Cold Sores Herpes Simplex Virus-1
FDA definition
Shortens time to healing of herpes simplex lesions on the lips, with time to healing defined as the time to patient described re-epithelialization.
Regulation
21 CFR 878.4860
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code OKJ

By decision year
4 clearances under product code OKJ with a decision year between 2012 and 2025, 2012 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OKJ by decision year
YearClearances
20121
20221
20241
20251

Applicants with the most clearances

Product code OKJ
Applicants holding the most 510(k) clearances under product code OKJ
ApplicantClearances
Light Tree Ventures Europe B.V.1
Luminance Medical Ventures, Inc.1
Shenzhen Nuon Medical Equipment Co., Ltd.1
Virulite, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code